DEVICE: KELYNIAM CSI (00810125927355)

Device Identifier (DI) Information

KELYNIAM CSI
PEEK-IM1004
Not in Commercial Distribution
PEEK-IM1004
KELYNIAM GLOBAL, INC.
00810125927355
GS1
June 23, 2025
1
785088829 *Terms of Use
PEEK Customized Cranial Implant, X-LARGE CSI061125-NK1
CLOSE

Device Characteristics

MR Safe
No
Yes
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
46268 Cranioplasty plate, non-alterable
An implantable shield designed to repair larger skull defects that is preformed before surgery and typically made of sheets of material [e.g., stainless steel, vitallium, titanium (Ti), plastic resins] that cannot be reshaped at the time of surgery without changing the physical or chemical properties of the material. The device is generally preformed with a central convex curvature matching the curvature of the forehead, side, or rear areas of the human adult skull; it is usually fixed to the intact cranial bones using screws and/or other fasteners. The device is used to repair defects due to injury, surgical intervention for tumour removal, congenital anomaly, or disease.
Active true
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
GXN Plate, Cranioplasty, Preformed, Non-Alterable
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K103582 000
No CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

5a947243-fc41-49ce-b516-8034c037635f
July 01, 2025
1
June 23, 2025
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
Yes
Yes
Yes
Yes CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE